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Clinical study for personalized therapy in Hepato-Pancreato-Biliary tumor patients based on neoantigens

Clinical study for personalized therapy in Hepato-Pancreato-Biliary tumor patients based on neoantigens

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800019876
Enrollment
Unknown
Registered
2018-12-05
Start date
2017-03-15
Completion date
Unknown
Last updated
2018-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepato-Pancreato-Biliary tumors

Interventions

Case series:personalized therapy based on neoantigens

Sponsors

Beijing Cancer Hospital / Peking University Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients have signed informed consent; 2. Aged between 18 and 75 years; 3. Patients who were diagnosed as initial, relapsed or metastasizd hepatocellular carcinoma, cholangiocarcinoma, or pancreatic cancer by pathology; 4. The tumor could not be treated with radical surgery resection according to the NCCN staging; 5. Patient who was under conventional chemotherapy, evaluated as SD or PD by RECIST1.1, and assessed by MDT that there wont be any clinical benefit after the conventional therapy. 6. Tumor tissue can be obtained by palliative surgical resection or needle puncture without causing uncontrollable serious complications; or paraffin-embedded tumor tissue or frozen tumor tissue within one year can be provided; 7. At least one lesion can be measured (>10 mm); 8. Enhanced CT or MRI examination can be accepted; 9. The ECOG score is 0 or 1; 10. The expected life expectancy of the patient is equal or greater than 4 months.

Exclusion criteria

Exclusion criteria: 1. The DNA QC (quality control) of the tumor tissue to be tested using whole exome sequencing(WES) does not reach the standard; 2. Neutrophil count <1.5 × 10^9/L, or hemoglobin <100g / L, or platelet count <80 × 10^9/L; 3. Bilirubin or serum creatinine is above the upper normal limit; 4. Patients with serious disease history in heart, brain, kidney, retina, muscle or other important organs or tissues; 5. Other circumstances that the investigator considered not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
overall survival;safety;Objective Response Rate;

Secondary

MeasureTime frame
Progression-Free-Survival;

Countries

China

Contacts

Public ContactChunyi Hao

Peking University Cancer Hospital

haochunyi@bjmu.edu.cn+86 13911501185

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026